Insecticide Treated bedNets (ITNs) for malaria control in Urban Accra

ISRCTN ISRCTN42261314
DOI https://doi.org/10.1186/ISRCTN42261314
Secondary identifying numbers N/A
Submission date
31/01/2008
Registration date
04/04/2008
Last edited
04/06/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Martin Donnelly
Scientific

Liverpool School of Tropical Medicine
Pembroke Place
Liverpool
L35QA
United Kingdom

Study information

Study designNon-randomised controlled trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Other
Study typePrevention
Scientific titleInsecticide Treated bedNets (ITNs) for malaria control in Urban Accra
Study objectivesThe main objectives of the study:
1. Assess if bednets can be used as rapid, high coverage control method for malaria in urban areas
2. Investigate the effect of ITN introduction on malaria, anaemia and anthropometric measurements
3. Assess the use of haemoglobin level as a measurement of intervention efficacy by controlling for nutritional and geohelminth confounding factors
Ethics approval(s)1. Liverpool School of Tropical Medicine, UK, approved on 23 September 2002 (ref: 02:50). Some amendments to the existing clearance were reviewed on the 30 April 2004 with additional approval granted on 3rd June 2004.
2. Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, ethical clearance granted in September 2002
Health condition(s) or problem(s) studiedMalaria and anaemia
InterventionInsecticide treated bednets vs no intervention (Control group received bednets after six months)

It was not possible to randomly allocate children to the two arms of the study as the intervention was community based. The insecticide treated nets were distributed in the intervention community and therefore all children surveyed in that community entered the intervention arm. All households with children under 10 and/or pregnant women in the control community received an insecticide treated nets after six months.

Duration of intervention: 6 months (although the insecticide treated nets remained the property of the study subjects)
Intervention typeOther
Primary outcome measureThe following were assessed at enrolment, 3 and 6 months:
1. Moderate anaemia, provisionally defined as a haemoglobin level <9 g/dl
2. Haemoglobin level as a continuous variable (in g/dl)
3. Density of infection defined as parasitaemia >5,000 parasites/mm3
Secondary outcome measuresNo secondary outcome measures
Overall study start date20/05/2004
Completion date17/12/2004

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit1 Month
Upper age limit10 Years
SexBoth
Target number of participants600
Total final enrolment498
Key inclusion criteriaChildren aged over 1 month and under 10 years
Key exclusion criteriaChildren with haemoglobin (Hb) <8g/dl who will require iron supplementation
Date of first enrolment20/05/2004
Date of final enrolment17/12/2004

Locations

Countries of recruitment

  • England
  • Ghana
  • United Kingdom

Study participating centre

Liverpool School of Tropical Medicine
Liverpool
L35QA
United Kingdom

Sponsor information

Liverpool School of Tropical Medicine (UK)
University/education

c/o Dr Martin Donnelly
Pembroke Place
Liverpool
L35QA
England
United Kingdom

Website http://www.liv.ac.uk/lstm/
ROR logo "ROR" https://ror.org/03svjbs84

Funders

Funder type

Government

The Department for International Development (DfID) Malaria Knowledge Programme of the Liverpool School of Tropical Medicine (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2010 04/06/2019 Yes No

Editorial Notes

04/06/2019: Total final enrolment and publication reference were added.